BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VM6

    MDR report key: 2508773 · Received March 26, 2012

    Report

    Report Number
    1218950-2012-00976
    Event Type
    Malfunction
    Date Received
    March 26, 2012
    Report Date
    March 7, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS-DUP
    Product Code
    MHX
    PMA / PMN Number
    K082280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED DESCRIPTION NOTES A VOLUME PROBLEM ON THE MONITOR. THIS COMPLAINT IS DEEMED REPORTABLE SINCE PHILIPS DOES NOT HAVE ENOUGH DATA TO VERIFY THAT THERE WAS NO SOUND COMING FROM THE SPEAKER. IN AN ABUNDANCE OF CAUTION, WE WILL REPORT THIS INCIDENT. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE REPORTED DESCRIPTION NOTES A VOLUME PROBLEM ON THE MONITOR. THIS COMPLAINT IS DEEMED REPORTABLE SINCE PHILIPS DOES NOT HAVE ENOUGH DATA TO VERIFY THAT THERE WAS NO SOUND COMING FROM THE SPEAKER. IN AN ABUNDANCE OF CAUTION, WE WILL REPORT THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VM6 MHX PHILIPS MEDICAL SYSTEMS-DUP 863064

    Patients

    Seq Age Sex Outcome Treatment
    1